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When developing a medical device, one of the key regulatory obligations manufacturers must meet is maintaining a Design History File (DHF). While most manufacturers associate DHF with Class II and Class III devices, even Class I medical devices have specific DHF requirements that cannot be overlooked. Understanding what the DHF requirement means, what documentation it involves, and how it fits into FDA regulations can help manufacturers stay compliant and avoid regulatory issues later.
In this blog, we’ll break down the DHF requirement for Class I medical devices, what to include, why it matters, and how to simplify the process for FDA compliance.
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What is a Design History File (DHF)?
A Design History File (DHF) is a collection of records that describe the design and development process of a medical device. The purpose of the DHF is to demonstrate that the device was developed in accordance with the design plan and regulatory requirements under 21 CFR 820.30 of the FDA Quality System Regulation (QSR).
In simple terms, your DHF shows the FDA how your product evolved from concept to final design and proves that proper controls and documentation were followed throughout.
Understanding FDA 21 CFR 820.30 and DHF Requirement
According to 21 CFR 820.30(j), each manufacturer must “establish and maintain a DHF for each type of device” to ensure that the design was developed according to the approved design plan and QSR requirements.
The DHF must include or reference:
- The design plan and its changes
- Design inputs (user needs, regulatory requirements, and performance criteria)
- Design outputs (drawings, specifications, production details)
- Design review records
- Design verification and validation results
- Design transfer records
- Design changes and justifications
This requirement applies to most medical devices, but there are specific exemptions for certain Class I devices based on their risk profile.
DHF Requirement for Class I Medical Devices
Not all Class I devices are subject to full design control requirements under the FDA’s QSR. However, that doesn’t mean Class I manufacturers can ignore DHF documentation entirely.
Here’s how the DHF requirement applies:
Exempt Class I Devices:
Many Class I devices are exempt from design controls under 21 CFR 820.30(a)(2)(i). These typically include devices with well-established designs, low risk, and minimal potential for harm. For such devices, a formal DHF may not be required.Non-Exempt Class I Devices:
Some Class I devices, especially those that are sterile, software-driven, or involve measuring functions, are not exempt. For these, maintaining a complete DHF is mandatory. This includes all records proving the design process met the FDA’s QSR.Practical Compliance:
Even if your Class I device is exempt, maintaining some level of design documentation is a best practice. The FDA expects manufacturers to have evidence that the device is safe, effective, and consistent in performance. A simplified DHF or design summary can serve as strong proof of compliance during inspections.
Why DHF Matters for Class I Devices
Manufacturers often underestimate the importance of maintaining a DHF for low-risk products. But in reality, a well-maintained DHF:
- Demonstrates compliance with FDA regulations
- Prevents costly redesigns by keeping track of changes and decisions
- Supports quality audits and inspections
- Protects intellectual property through documented design evolution
- Facilitates future upgrades or submissions if the device classification changes
Without proper documentation, even small issues—like a material change or a production adjustment—can lead to compliance risks or rework later.
Key Elements of a DHF for Class I Devices
If your Class I device falls under the DHF requirement, here’s what your file should typically contain:
Design and Development Plan
Outline stages, responsibilities, and deliverables.
Define when design reviews will occur.
Design Inputs
Include user requirements, safety standards, intended use, and applicable regulations.
Design Outputs
List specifications, drawings, and production documents that match the inputs.
Design Reviews
Record meeting notes, feedback, and approvals from each stage.
Design Verification
Document testing and evaluation proving outputs meet inputs.
Design Validation
Include evidence showing the final product performs as intended under actual use conditions.
Design Transfer
Show how the design was successfully transferred to production.
Design Changes
Maintain a log of revisions, reasons for changes, and their impact assessments.
For Class I devices, the depth of documentation may vary, but the process itself should always follow a logical, traceable path.
Common Mistakes Manufacturers Make
Here are a few pitfalls small manufacturers or startups often face regarding DHF:
- Assuming that Class I devices are completely exempt from DHF
- Failing to maintain traceability between design inputs and outputs
- Not documenting design changes or review decisions
- Keeping records scattered across different departments or tools
- Neglecting verification and validation documentation
These mistakes can trigger FDA warning letters or complicate future filings if the device is modified or reclassified.
Best Practices for Managing DHF
To make your DHF process smoother:
- Use a centralized electronic DHF (eDHF) system for version control
- Maintain traceability matrices linking inputs, outputs, verifications, and validations
- Conduct periodic internal audits to ensure documentation accuracy
- Involve cross-functional teams (engineering, QA, regulatory) in reviews
- Create templates and checklists to ensure completeness
By building a strong DHF foundation early, you can simplify audits, speed up product updates, and maintain a clean regulatory record.
Get DHF documentation support from FDA experts
How Operon Strategist Can Help
Operon Strategist is a leading regulatory and medical device consulting firm that helps startups and manufacturers meet global compliance standards. We provide end-to-end support for medical device design documentation, including DHF preparation, FDA 21 CFR 820 compliance, and quality management system implementation.
Our team assists clients with:
- DHF documentation and gap analysis
- QMS setup as per ISO 13485 and FDA QSR
- FDA registration and 510(k) submissions
- Design control process mapping and training
- Turnkey project consulting for manufacturing setup
With extensive experience in the US regulatory framework, we help clients create compliant and audit-ready DHFs, ensuring their products meet FDA expectations from the start.
If you’re developing a Class I medical device and want to ensure your documentation aligns with FDA requirements, reach out to our experts at Operon Strategist.
